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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA 9 LONG R 130 L340 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA 9 LONG R 130 L340 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 472.412S
Device Problem Break (1069)
Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a valgus malalignment and a not fully healed femur fracture were diagnosed through x-ray images. A revision surgery was performed on (b)(6) 2020 to correct the valgus malalignment. During the revision it was noticed that the proximal femoral nail antirotation (pfna) nail was broken. The pfna was revised. No further information provided. Concomitant devices reported: pfna blade perf l90 tan (part 04. 027. 033s, lot 50p9419, quantity 1); lockscr ø5 l36 f/nails tan light green (part 04. 005. 526s, lot 5l66048, quantity 1); lockscr ø5 l38 f/nails tan light green (part 04. 005. 528s, lot 6l89022, quantity 1). This report is for one (1) pfna ø9 long r 130° l340 tan. This is report 3 of 4 for (b)(4).
 
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Brand NamePFNA 9 LONG R 130 L340 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10868377
MDR Text Key217335176
Report Number8030965-2020-09061
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number472.412S
Device Lot NumberL798145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/19/2020 Patient Sequence Number: 1
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